The present invention relates, in general, to remotely controlled surgical instruments, and more particularly, to a method of remotely controlling a surgical biopsy instrument including an apparatus for remotely selecting a particular mode of operation.
The diagnosis and treatment of patients with cancerous tumors, pre-malignant conditions, and other disorders has long been an area of intense investigation. Non-invasive methods for examining tissue include: palpation, X-ray imaging, magnetic resonance imaging (MRI), computed tomography (CT), and ultrasound imaging. When a physician suspects that tissue may contain cancerous cells, a biopsy may be done using either an open procedure or a percutaneous procedure. For an open procedure, a scalpel is used to create a large incision to provide direct visualization of and access to the tissue mass of interest. The entire mass (excisional biopsy) or a part of the mass (incisional biopsy) may then be removed. In percutaneous biopsy procedures, a needle-shaped instrument is inserted through a small incision to access the tissue mass of interest and obtain a tissue sample for later examination and analysis.
Aspiration and core sampling are two percutaneous methods for obtaining tissue from within the body. In an aspiration procedure, tissue is fragmented into pieces and drawn through a fine needle in a fluid medium. The aspiration method is less intrusive than most other sampling techniques, however, it has limited application since the structure of tissue excised by aspiration is destroyed, leaving only individual cells for analysis. In core biopsy, a core or fragment of tissue is obtained in a manner which preserves both the individual cell and the tissue structure for histological examination. The type of biopsy used depends on various factors, no single procedure is ideal for all cases.
Ethicon Endo-Surgery, Inc., Cincinnati, Ohio currently markets a core sampling biopsy instrument under the MAMMOTOME trademark. The MAMMOTOME biopsy instrument is normally mounted on a movable mechanical arm attached to an X-ray stereotactic imaging device. The MAMMOTOME biopsy instrument is adapted to obtain multiple tissue samples from a patient with only one percutaneous insertion of a piercing element or piercer into the patient""s breast. An operator uses the MAMMOTOME biopsy instrument to xe2x80x9cactivelyxe2x80x9d capture (using a vacuum) tissue prior to severing it from surrounding tissue. Tissue is drawn into a lateral port at the distal end of the piercer by a remotely actuated vacuum system. Once the tissue is in the lateral port, a cutter is rotated and advanced through a lumen of the piercer past the lateral port. As the cutter advances past the lateral port opening, it severs the tissue in the port from the surrounding tissue. When the cutter retracts it pulls the tissue with it and deposits the tissue sample outside of the patient""s body. The cutter is rotated using a motor, but the operator manually advances and retracts the cutter manually by moving a knob mounted on the outside of the instrument. The operator has tactile and audible feedback to determine whether the cutter is effectively cutting tissue. An alternative instrument wherein the cutter is advanced and retracted manually is illustrated and described in U.S. patent applications Ser. Nos. 09/282,142 and 09/282,140.
Related patent applications, Ser. No. 09/282,142 and Ser. No. 09/282,140 also describe a control method and apparatus for an automatic, core sampling biopsy device. In one embodiment, cutter translation and rotation are driven by motors separate from the handpiece and operatively connected by a control cord and a pair of flexible, rotatable shafts. The operator steers the piercer of the handpiece towards a suspect tissue mass visualized using, for example, a handheld ultrasound-imaging device. Buttons on the handpiece generally enable the operator to advance or retract the cutter to obtain a tissue sample, or to activate the vacuum to draw in tissue.
A common problem encountered by operators when using some types of automatic, powered surgical devices is the need for the operator to move back and forth between the patient and a control unit physically separated from the patient. Reaching out to change a setting or mode could require that the operator move from a sterile, surgical field to a non-sterile area, and back again. In a surgical instrument which has a plurality of operational modes, the operator selects a particular mode and the associated control unit automatically operates the device through selected portions of the surgical procedure. For breast biopsy procedures using handheld biopsy devices such those described above, the operator may also need to use both hands during the procedure, one to hold the instrument and one to for example, palpate tissue or to use a handheld ultrasonic imaging device to locate a possible lesion As an example, either immediately before or after the piercer is inserted into the suspected tissue, the operator enables a mode of operation which may be referred to as a Sampling Mode of operation wherein the cutter is automatically advanced to collect a tissue sample. It is highly undesirable at this point for the operator to free one hand and to reach over to the control unit to actuate a control in order to select and enable the Sampling Mode of operation. Since a surgical biopsy device may have a plurality of operational modes, it is desirable to be able to xe2x80x9cscrollxe2x80x9d among possible operational mode choices, make a selection, and enable the selected mode, without releasing the handpiece or leaving the surgical field. The operational mode choices, or xe2x80x9cmenuxe2x80x9d, may be viewed, for example, on a display provided with the surgical biopsy device.
Numerous types of surgical biopsy systems having various types of control devices are known in the art. U.S. Pat. No. 5,769,086 discloses an automatic control system for a vacuum-assisted automatic core biopsy device. The system in U.S. Pat. No. 5,769,086 may be used with an imaging device having a monitor for viewing still images of tissue. A hand-operated cursor (mouse) is used to click on portions of the tissue image viewed on the monitor to automatically direct a needle of the biopsy device to the tissue. U.S. Pat. No. 5,830,219 discloses a rotary cutting surgical instrument mounted on the needle guiding stage of a stereotactic mammography biopsy system. The system in U.S. Pat. No. 5,830,219 is provided with a controlling means having motor controls. Neither Ritchart nor Bird, however, disclose a control adapted for remotely selecting and/or enabling an operational mode from a menu shown on a display without leaving the surgical field.
It would, therefore, be advantageous to develop a method of remotely controlling the operational mode of a surgical biopsy system having at least one remotely located (from the control unit) control button for selecting and enabling an operational mode. It would further be advantageous to develop a method of remotely controlling the operational mode of a surgical biopsy system wherein an operator, without leaving the surgical field, may actuate remotely located control button(s) to change an operational mode while performing a biopsy procedure. It would further be advantageous to develop a method of remotely controlling the operational mode of a surgical biopsy system wherein an operator may visualize the available plurality of operational modes of the surgical biopsy device and actuate remotely located control button(s) to scroll through the operational modes and to enable selected operational mode.
The present invention is a method for selecting an operational mode of a surgical biopsy system for removing at least one tissue sample from a surgical patient. The surgical biopsy system includes a handpiece having an elongated, hollow piercer and a cutter rotatably and axially positionable relative to the piercer. The piercer has a lateral port for receiving a tissue sample. The surgical biopsy system further comprises a control unit, a display showing a plurality of operational modes of the surgical biopsy system, and at least one control button remotely located from the control unit and operatively connected to the control unit by a circuit. The method comprises the steps of visualizing the plurality of operational modes on the display, and actuating the remotely located control button to scroll through the plurality of operational modes on the display to select a desired operational mode. In another embodiment of a method according to the present invention, the method further comprises the step of actuating the control button to enable the desired operational mode.
One potential operational mode is a sampling mode in which the cutter is rotated and translated to sever tissue in the lateral port. The sampling mode then continues by translating the cutter back to its rest position and depositing the tissue sample on a collection surface of the surgical biopsy system. In one embodiment of the invention, the sampling mode is selected and activated by when an operator uses a control button to select an icon representative of the sampling mode and to actuate the sampling mode once the icon is selected.
In a further embodiment of a method according to the present invention, a plurality of control buttons including a forward button, a reverse button, and a vacuum button are included in the handpiece. The forward, reverse, and vacuum buttons are operatively connected to a remotely located control unit which includes a visual display. The display includes a plurality of icons representative of a plurality of operational modes. In a method according to the present invention, the operator: i) visualizes the plurality of icons; ii) actuates one of the control buttons to enable a scrolling routine; iii) selects an icon representative of a desired operational mode whereby the icon representative of the selected operational mode becomes visually distinguished from the other icons on the display; and iv) actuates one of the control buttons to initiate the selected operational mode.